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§ 40.41 Where does a urine collection for a DOT drug test take place?
(a) A urine collection for a DOT drug test must take place in a collection site meeting the requirements of this section.
(b) If you are operating a collection site, you must ensure that it meets the security requirements of §40.43.
(c) If you are operating a collection site, you must have all necessary personnel, materials, equipment, facilities and supervision to provide for the collection, temporary storage, and shipping of urine specimens to a laboratory, and a suitable clean surface for writing.
(d) Your collection site must include a facility for urination described in either paragraph (e) or paragraph (f) of this section.
(e) The first, and preferred, type of facility for urination that a collection site may include is a single-toilet room, having a full-length privacy door, within which urination can occur.
(1) No one but the employee may be present in the room during the collection, except for the observer in the event of a directly observed collection.
(2) You must have a source of water for washing hands, that, if practicable, should be external to the closed room where urination occurs. If an external source is not available, you may meet this requirement by securing all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and providing moist towelettes outside the closed room.
(f) The second type of facility for urination that a collection site may include is a multistall restroom.
(1) Such a site must provide substantial visual privacy (e.g., a toilet stall with a partial-length door) and meet all other applicable requirements of this section.
(2) If you use a multi-stall restroom, you must either—
(i) Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or
(ii) Conduct all collections in the facility as monitored collections (see §40.69 for procedures). This is the only circumstance in which you may conduct a monitored collection.
(3) No one but the employee may be present in the multistall restroom during the collection, except for the monitor in the event of a monitored collection or the observer in the event of a directly observed collection.
(g) A collection site may be in a medical facility, a mobile facility (e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section.
§ 40.43 What steps must operators of collection sites take to protect the security and integrity of urine collections?
(a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection to deter tampering with specimens:
(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);
(2) Ensure that the water in the toilet is blue;
(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present;
(4) Inspect the site to ensure that no foreign or unauthorized substances are present;
(5) Tape or otherwise secure shut any movable toilet tank, or put bluing in the tank;
(6) Ensure that undetected access (e.g., through a door not in your view) is not possible;
(7) Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and
(8) Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site’s continued integrity.
(c) If the collection site uses a facility normally used for other purposes, like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection that:
(1) Access to collection materials and specimens is effectively restricted; and
(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(d) As a collector, you must take the following additional steps to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “shy bladder” situation (see §40.193(b)), you may conduct a collection for another employee.
(2) To the greatest extent you can, keep an employee’s collection container within view of both you and the employee between the time the employee has urinated and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee who handles the specimen before it is poured into the bottles and sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout the collection process.
(e) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer (e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (e).
(2) Except for the observer in a directly observed collection or the monitor in the case of a monitored collection, you must not permit anyone to enter the urination facility in which employees provide specimens.
(3) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted
into the site.
(4) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection
(f) If you are operating a collection site, you must minimize the number of persons handling specimens.
§ 40.45 What form is used to document a DOT urine collection?
(a) The Federal Drug Testing Custody and Control Form (CCF) must be used to document every urine collection required by the DOT drug testing program. You may view this form on the Department’s web site (http://www.dot.gov/odapc) or the HHS web site (http://www.workplace.samhsa.gov).
(b) You must not use a non-Federal form or an expired CCF to conduct a DOT urine collection. As a laboratory, C/TPA or other party that provides CCFs to employers, collection sites, or other customers, you must not provide copies of an expired CCF to these participants. You must also affirmatively notify these participants that they must not use an expired CCF (e.g., that after November 30, 2011, they must not use an expired CCF for DOT urine collections).
(c) As a participant in the DOT drug testing program, you are not permitted to modify or revise the CCF except as follows:
(1) You may include, in the area outside the border of the form, other information needed for billing or other purposes necessary to the collection process.
(2) The CCF must include the names, addresses, telephone numbers and fax numbers of the employer and the MRO, which may be preprinted, typed, or handwritten. The MRO information must include the specific physician’s name and address, as opposed to only a generic clinic, health care organization, or company name. This information is required, and it is prohibited for an employer, collector, service agent or any other party to omit it. In addition, a C/TPA’s name,
address, fax number, and telephone number may be included, but is not required. The employer may use a C/TPA’s address in place of its own, but must continue to include its name, telephone number, and fax number.
(3) As an employer, in Step 1-D of the CCF you may preprint the box for the DOT Agency under whose authority the test will occur.
(4) As a collector, you may use a CCF with your name, address, telephone number, and fax number preprinted, but under no circumstances may you sign the form before the collection event.
(5) When using an electronic CCF, you must establish adequate confidentiality and security measures to ensure that confidential employee records are not available to unauthorized persons. This includes protecting the physical security of records, access controls, and computer security measures to safeguard confidential data in electronic form.
(d) Under no circumstances may the CCF transmit personal identifying information about an employee (other than a social security number (SSN) or other employee identification (ID) number) to a laboratory.
(e) As an employer, you may use an equivalent foreign-language version of the CCF approved by ODAPC. You may use such a non-English language form only in a situation where both the employee and collector understand and can use the form in that language.
(f) An employer who uses an electronic CCF must ensure that the collection site, the primary and split laboratories, and MRO have compatible systems, and that the employee and any other program participants in the testing process will receive a legible copy of the CCF.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001; 75 FR 59107, September 27, 2010; 76 FR 59577,
September 27, 2011; 80 FR 19553, April 13, 2015]
§ 40.47 May employers use the CCF for non-Federal collections or non-Federal forms for DOT collections?
(a) No, as an employer, you are prohibited from using the CCF for non-Federal urine collections. You are also prohibited from using non-Federal forms for DOT urine collections. Doing either subjects you to enforcement action under DOT agency regulations.
(b) (1) In the rare case where the collector, either by mistake or as the only means to conduct a test under difficult circumstances (e.g., post-accident or reasonable suspicion test with insufficient time to obtain the CCF), uses a non-Federal form for a DOT collection, the use of a non-Federal form does not present a reason for the laboratory to reject the specimen for testing or for an MRO to cancel the result.
(2) The use of the non-Federal form is a “correctable flaw.” As an MRO, to correct the problem you must follow the procedures of §40.205(b(2).
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001]
§ 40.49 What materials are used to collect urine specimens?
For each DOT drug test, you must use a collection kit meeting the requirements of Appendix A of this part.
§ 40.51 What materials are used to send urine specimens to the laboratory?
(a) Except as provided in paragraph (b) of this section, you must use a shipping container that adequately protects the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory courier hand-delivers the specimens from the collection site to the laboratory.